Case Series Drug Analysis Print Name: Isotretinoin
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1 Report Run Date: 30-Dec-2013 Data Lock Date: 27-Dec :09:23 Earliest Reaction Date: 12-Jun-1997 MedDRA Version: MedDRA 16.1 Isotretinoin: No description provided. Report Run Date: 30-Dec-2013, Page 1
2 Blood disorders Leukopenias NEC Leukopenia 1 0 Marrow depression and hypoplastic anaemias Aplastic anaemia 1 0 Neutropenias Febrile neutropenia 1 0 Neutropenia 1 0 Thrombocytopenias Thrombocytopenia 1 0 Blood disorders SOC TOTAL 5 0 Report Run Date: 30-Dec-2013, Page 2
3 Cardiac disorders Cardiac signs and symptoms NEC Palpitations 3 0 Cardiac disorders SOC TOTAL 3 0 Report Run Date: 30-Dec-2013, Page 3
4 Congenital disorders Ocular disorders congenital NEC Colour blindness 1 0 Congenital disorders SOC TOTAL 1 0 Report Run Date: 30-Dec-2013, Page 4
5 Ear disorders Hearing losses Deafness 1 0 Inner ear signs and symptoms Tinnitus 3 0 Ear disorders SOC TOTAL 4 0 Report Run Date: 30-Dec-2013, Page 5
6 Endocrine disorders Thyroid hyperfunction disorders Hyperthyroidism 1 0 Thyroid hypofunction disorders Hypothyroidism 1 0 Endocrine disorders SOC TOTAL 2 0 Report Run Date: 30-Dec-2013, Page 6
7 Eye disorders Blindness (excl colour blindness) Blindness unilateral 1 0 Night blindness 1 0 Choroid and vitreous structural change, deposit and degeneration Vitreous floaters 1 0 Lacrimation disorders Dry eye 7 0 Lid, lash and lacrimal infections, irritations and inflammations Blepharitis 1 0 Ocular disorders NEC Eye pain 2 0 Ocular infections, inflammations and associated manifestations Eye inflammation 1 0 Eye pruritus 1 0 Ocular sensation disorders Asthenopia 1 0 Foreign body sensation in eyes 2 0 Visual disorders NEC Vision blurred 2 0 Visual impairment 1 0 Visual field disorders Scotoma 1 0 Eye disorders SOC TOTAL 22 0 Report Run Date: 30-Dec-2013, Page 7
8 Gastrointestinal disorders Acute and chronic pancreatitis Pancreatitis 1 0 Colitis (excl infective) Inflammatory bowel disease 1 0 Dental and periodontal infections and inflammations Dental caries 1 0 Dental disorders NEC Tooth disorder 1 0 Dyspeptic signs and symptoms Dyspepsia 4 0 Gastrointestinal and abdominal pains (excl oral and throat) Abdominal pain 2 0 Abdominal pain upper 1 0 Gastrointestinal atonic and hypomotility disorders NEC Constipation 2 0 Gastrointestinal disorders NEC Gastrointestinal disorder 1 0 Gastrointestinal spastic and hypermotility disorders Irritable bowel syndrome 3 0 Gingival disorders NEC Gingival disorder 1 0 Haemorrhoids and gastrointestinal varices (excl oesophageal) Haemorrhoids 1 0 Malabsorption syndromes Coeliac disease 3 0 Nausea and vomiting symptoms Nausea 2 0 Vomiting 1 0 Oesophagitis (excl infective) Oesophagitis 1 0 Oral dryness and saliva altered Dry mouth 2 0 Lip dry 4 0 Oral soft tissue swelling and oedema Lip swelling 1 0 Stomatitis and ulceration Mouth ulceration 1 0 Gastrointestinal disorders SOC TOTAL 34 0 Report Run Date: 30-Dec-2013, Page 8
9 General disorders Adverse effect absent No adverse event 1 0 Application and instillation site reactions Application site inflammation 1 0 Application site pain 1 0 Asthenic conditions Asthenia 1 0 Fatigue 7 0 Malaise 4 0 Feelings and sensations NEC Feeling abnormal 2 0 Feeling cold 1 0 Temperature intolerance 1 0 Gait disturbances Gait disturbance 1 0 General signs and symptoms NEC Crying 1 0 Irritability 3 0 Unevaluable event 1 0 Interactions Alcohol interaction 1 0 Drug interaction 1 0 Mucosal findings abnormal Mucosal dryness 1 0 Pain and discomfort NEC Chest discomfort 1 0 Pain 2 0 Ulcers NEC Ulcer 1 0 General disorders SOC TOTAL 32 0 Report Run Date: 30-Dec-2013, Page 9
10 Immune system disorders Anaphylactic responses Anaphylactic reaction 1 0 Immunodeficiency disorders NEC Immunodeficiency 1 0 Immune system disorders SOC TOTAL 2 0 Report Run Date: 30-Dec-2013, Page 10
11 Infections Bacterial infections NEC Meningitis bacterial 1 0 Dental and oral soft tissue infections Gingivitis 1 0 Lower respiratory tract and lung infections Lower respiratory tract infection 1 0 Skin structures and soft tissue infections Acne pustular 1 0 Paronychia 1 0 Infections SOC TOTAL 5 0 Report Run Date: 30-Dec-2013, Page 11
12 Injuries Exposures associated with pregnancy, delivery and lactation Exposure during pregnancy 4 0 Maternal exposure timing unspecified 1 0 Foetal and neonatal conditions associated with product exposure Maternal drugs affecting foetus 1 0 Non-site specific injuries NEC Injury 1 0 Overdoses Intentional overdose 1 0 Overdose 2 0 Skin injuries NEC Scar 1 0 Injuries SOC TOTAL 11 0 Report Run Date: 30-Dec-2013, Page 12
13 Investigations Digestive enzymes Amylase increased 1 0 Liver function analyses Transaminases increased 1 0 Physical examination procedures and organ system status Body height decreased 1 0 Platelet analyses Platelet count decreased 1 0 Vascular tests NEC (incl blood pressure) Blood pressure increased 1 0 Investigations SOC TOTAL 5 0 Report Run Date: 30-Dec-2013, Page 13
14 Metabolic disorders Appetite disorders Decreased appetite 2 0 Calcium metabolism disorders Hypercalcaemia 1 0 Electrolyte imbalance NEC Electrolyte imbalance 1 0 Potassium imbalance Hyperkalaemia 2 0 Sodium imbalance Hyponatraemia 1 0 Metabolic disorders SOC TOTAL 7 0 Report Run Date: 30-Dec-2013, Page 14
15 Muscle & tissue disorders Epiphyseal disorders Epiphyseal disorder 1 0 Epiphyses premature fusion 1 0 Joint related signs and symptoms Arthralgia 8 0 Muscle pains Myalgia 1 0 Muscle related signs and symptoms NEC Muscle disorder 1 0 Musculoskeletal and connective tissue pain and discomfort Back pain 8 0 Musculoskeletal pain 2 0 Neck pain 2 0 Pain in extremity 1 0 Musculoskeletal and connective tissue signs and symptoms NEC Growth retardation 2 0 Rheumatoid arthropathies Rheumatoid arthritis 1 0 Muscle & tissue disorders SOC TOTAL 28 0 Report Run Date: 30-Dec-2013, Page 15
16 Nervous system disorders Disturbances in consciousness NEC Lethargy 1 0 Facial cranial nerve disorders VIIth nerve paralysis 1 0 Headaches NEC Headache 5 0 Memory loss (excl dementia) Memory impairment 3 0 Mental impairment (excl dementia and memory loss) Disturbance in attention 5 0 Mental impairment 1 0 Migraine headaches Migraine 1 0 Optic nerve disorders NEC Optic neuritis 1 0 Nervous system disorders SOC TOTAL 18 0 Report Run Date: 30-Dec-2013, Page 16
17 Pregnancy conditions Abortions not specified as induced or spontaneous Abortion 1 0 Abortions spontaneous Abortion spontaneous 1 0 Foetal growth complications Foetal growth restriction 1 0 Normal pregnancy, labour and delivery Pregnancy 6 0 Unintended pregnancies Pregnancy on oral contraceptive 1 0 Pregnancy conditions SOC TOTAL 10 0 Report Run Date: 30-Dec-2013, Page 17
18 Psychiatric disorders Abnormal behaviour NEC Abnormal behaviour 1 0 Affect alterations NEC Flat affect 1 0 Anxiety disorders NEC Anxiety disorder 1 0 Anxiety symptoms Anxiety 16 0 Stress 2 0 Behaviour and socialisation disturbances Aggression 3 0 Asocial behaviour 1 0 Homicidal ideation 1 0 Paranoia 2 0 Personality change 3 0 Social avoidant behaviour 2 0 Confusion and disorientation Disorientation 2 0 Delusional symptoms Delusion 2 0 Depressive disorders Depression 35 0 Depression suicidal 1 1 Major depression 1 0 Disturbances in initiating and maintaining sleep Insomnia 2 0 Emotional and mood disturbances NEC Anger 5 0 Mood altered 2 0 Fear symptoms and phobic disorders (incl social phobia) Autophobia 1 0 Fluctuating mood symptoms Mood swings 4 0 Mood alterations with depressive symptoms Depressed mood 4 0 Tearfulness 1 0 Mood alterations with manic symptoms Mania 1 0 Mood disorders NEC Apathy 1 0 Orgasmic disorders and disturbances Premature ejaculation 1 0 Panic attacks and disorders Panic attack 3 0 Panic disorder 1 0 Perception disturbances Hallucination, auditory 3 0 Personality disorders NEC Personality disorder 1 0 Psychiatric symptoms NEC Psychiatric symptom 2 0 Psychotic disorder NEC Acute psychosis 1 0 Report Run Date: 30-Dec-2013, Page 18
19 Psychiatric disorderspsychiatric disorders cont'd Psychotic disorder 3 0 Sleep disorders NEC Sleep disorder 1 0 Somatoform disorders Conversion disorder 1 0 Substance-related disorders Alcohol abuse 1 0 Withdrawal syndrome 1 0 Suicidal and self-injurious behaviour Completed suicide Intentional self-injury 4 0 Self injurious behaviour 2 0 Self-injurious ideation 2 0 Suicidal behaviour 1 0 Suicidal ideation 17 0 Suicide attempt 7 0 Psychiatric disorders SOC TOTAL Report Run Date: 30-Dec-2013, Page 19
20 Renal & urinary disorders Glomerulonephritis and nephrotic syndrome Focal segmental glomerulosclerosis 1 0 Glomerulonephritis membranoproliferative 1 0 Nephropathies and tubular disorders NEC Renal tubular disorder 1 0 Renal & urinary disorders SOC TOTAL 3 0 Report Run Date: 30-Dec-2013, Page 20
21 Reproductive & breast disorders Breast signs and symptoms Breast tenderness 1 0 Erection and ejaculation conditions and disorders Erectile dysfunction 5 0 Menstruation and uterine bleeding NEC Menstruation irregular 1 0 Sexual function and fertility disorders NEC Sexual dysfunction 4 0 Vulvovaginal disorders NEC Vaginal haemorrhage 1 0 Vulvovaginal signs and symptoms Vulvovaginal pain 1 0 Reproductive & breast disorders SOC TOTAL 13 0 Report Run Date: 30-Dec-2013, Page 21
22 Respiratory disorders Nasal disorders NEC Epistaxis 5 0 Nasal dryness 1 0 Respiratory disorders SOC TOTAL 6 0 Report Run Date: 30-Dec-2013, Page 22
23 Skin disorders Acnes Acne 2 0 Alopecias Alopecia 5 0 Alopecia areata 1 0 Angioedemas Angioedema 1 0 Apocrine and eccrine gland disorders Hyperhidrosis 1 0 Bullous conditions Blister 1 0 Dermal and epidermal conditions NEC Dry skin 7 0 Skin disorder 1 0 Skin reaction 1 0 Skin sensitisation 2 0 Dermatitis and eczema Dermatitis allergic 1 0 Exfoliative conditions Skin exfoliation 1 0 Nail and nail bed conditions (excl infections and infestations) Nail growth abnormal 1 0 Photosensitivity and photodermatosis conditions Photosensitivity reaction 2 0 Pilar disorders NEC Hair growth abnormal 1 0 Skin hypoplasias and atrophies Skin atrophy 2 0 Urticarias Urticaria 1 0 Skin disorders SOC TOTAL 31 0 Report Run Date: 30-Dec-2013, Page 23
24 Social circumstances Criminal activity Homicide 1 0 Family and partner issues Pregnancy of partner 1 0 Social circumstances SOC TOTAL 2 0 Report Run Date: 30-Dec-2013, Page 24
25 Surgical & medical procedures Induced abortions Abortion induced 1 0 Surgical & medical procedures SOC TOTAL 1 0 Report Run Date: 30-Dec-2013, Page 25
26 Vascular disorders Peripheral vasoconstriction, necrosis and vascular insufficiency Raynaud's phenomenon 1 0 Vascular disorders SOC TOTAL 1 0 TOTAL REACTIONS FOR DRUG TOTAL REPORTS 121 TOTAL FATAL OUTCOME REPORTS 11 Report Run Date: 30-Dec-2013, Page 26
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